Clinical Trial

Ondansetron Use for Preventing Pruritus in Patients Undergoing Cesarean Section

Recruiting Phase 1
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Record status
This record was last updated March 28, 2025 (before its estimated August 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Opioids are often added with a local anesthetic to enhance the duration and quality of spinal anesthesia for cesarean delivery patients. However, spinal opioids are associated with a wide variety of side effects such as nausea, vomiting, (N/V) and pruritus (itching). The occurrence of pruritus can vary between 30% and 100% making pruritus the most common side-effect of intrathecal opioids and this rate is even higher in pregnant patients. Pruritus may require treatment which can be ineffective or sometimes reverse the analgesic effect of the opioids. Ondansetron is a safe and very commonly used Serotonin receptor antagonist treatment for local anesthetic opioid-induced pruritus used in pregnancy. The effect of different administration times of ondansetron in reducing pruritus or N/V in cesarean section (CS) cases has not been extensively studied and thus, this prospective study can help guide future clinical management of side effects caused by spinal intrathecal morphine administration.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-03-05; most recent amendment 2025-03-24.
Status change: Not Yet Recruiting → Recruiting 2025-03-24
Trial Details
NCT Number NCT06297499
Lead Sponsor Wayne State University
Conditions Pruritus Caused by Drug
Enrollment 66 participants
Start Date 2024-08-22
Primary Completion 2025-08-01 (estimated)
Study Completion 2025-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-28